Back to resultsVision II: Evaluation of GALILEO Intravascular Radiotherapy System
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Guidant GALILEO Intravascular Radiotherapy System
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria: Patient with angor, patients with only one de novo lesion. Target zone must be < 52 mm, artery section must be < 3,7mm and > 2,25 mm Exclusion Criteria: Vessel with extremely tortuous proximal segment, lesion with angulous segments (>90°) Unstable ventricular arrhythmia, dialysis, MI within the last 72 hours etc…
Sites / Locations
- Clinique St. Hilaire
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Treatment of single or multivessel long diffuse coronary stenosis with the Guidant GALILEO Intravascular Radiotherapy System
Outcomes
Primary Outcome Measures
MACE
Secondary Outcome Measures
All adverse cardiac or extra cardiac events
Full Information
NCT ID
NCT00180583
First Posted
September 15, 2005
Last Updated
July 31, 2008
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT00180583
Brief Title
Vision II: Evaluation of GALILEO Intravascular Radiotherapy System
Official Title
Vision II: Non Randomized French Evaluation of GALILEO Intravascular Radiotherapy System in Patients With de Novo Coronary Arteries Lesions by Restenosis on Angioplasty or Restenosis on Endoprosthesis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott Medical Devices
4. Oversight
5. Study Description
Brief Summary
To assess the safety and effectiveness of intravascular brachytherapy for the treatment of intrastent restenosis of coronary lesions with the Galileo system
Detailed Description
The purpose of this study is to evaluate the cardiac events (MACE) and adverse extra cardiac events at 6 month follow up and up to 24 months for the patients treated with Galileo system
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
268 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Treatment of single or multivessel long diffuse coronary stenosis with the Guidant GALILEO Intravascular Radiotherapy System
Intervention Type
Device
Intervention Name(s)
Guidant GALILEO Intravascular Radiotherapy System
Intervention Description
Treatment of single or multivessel long diffuse coronary stenosis with the Guidant GALILEO Intravascular Radiotherapy System
Primary Outcome Measure Information:
Title
MACE
Time Frame
6 months
Secondary Outcome Measure Information:
Title
All adverse cardiac or extra cardiac events
Time Frame
24-month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with angor, patients with only one de novo lesion. Target zone must be < 52 mm, artery section must be < 3,7mm and > 2,25 mm
Exclusion Criteria:
Vessel with extremely tortuous proximal segment, lesion with angulous segments (>90°) Unstable ventricular arrhythmia, dialysis, MI within the last 72 hours etc…
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques BERLAND, MD
Organizational Affiliation
Clinique St Hilaire, Rouen, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique St. Hilaire
City
Rouen
Country
France
12. IPD Sharing Statement
Learn more about this trial
Vision II: Evaluation of GALILEO Intravascular Radiotherapy System
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